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Completed

NCT Number: NCT00226915

Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma

The purpose of the study is to compare progression-free survival of conventional paclitaxel and carboplatin vs weekly paclitaxel and carboplatin in patients with newly diagnosed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Primary Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

About this study

This is a randomized, multicenter study. Patients are stratified according to residual disease 1 cm or less vs more than 1cm, stage II vs III vs IV, and histology (clear cell or mucinous vs. serous or others). Patients are randomized to one of two treatment arms.

Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 60 minutes on day 1 for 6-9 cycles.

Arm II: Patients receive paclitaxel IV over 1 hour days 1, 8, and 15 and carboplatin IV over 60 minutes on day 1 for 6-9 cycles.

In both arms, cycles repeat 6 cycles every 21 days in the absence of disease progression or unacceptable toxicity. Additional 3 cycles are given if clinical partial or complete response after 6 cycles.

PROJECTED ACCRUAL: A total 600 patients (300 per treatment arm) will be accrued for this study within 3 years. Assuming median progression-free survivals of 16 months and 21 months and a recruitment period of 3 years this can be achieved by recruiting 600 patients designed to have 80 % detect to a difference between the two arms at the two-sided 5% level of statistical significance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • No prior chemotherapy
  • Age: 20 and more
  • Performance status: ECOG 0-3
  • 1) Absolute neutrophil count at least 1,500/mm3 2) Platelet count at least 100,000/mm3 3) Bilirubin less than 1.5mg/dL 4) SGOT less than 100 IU/l 5) Serum creatinine less than 1.5mg/dL
  • Written informed consent

Exclusion criteria

  • Patients with ovarian borderline tumor
  • Patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer that is curable with local therapy
  • Patients with active infection or uncontrolled diabetes
  • Patients with unstable angina, or those who have had a myocardial infarction within the past 6 months, or patients with serious arrythmia that requires medication
  • Patients who have a history of hypersensitivity to polyoxyethylated castor oil (Cremophor EL)

Treatment and study plan

Paclitaxel+Carboplatin

Drug

Paclitaxel 180mg/m2＋CBDCA AUC6 q21 days x 6-9cycles

Primary outcomes

  1. Progression Free Suvaival

    Time frame: During the protocol treatment then 18 months from the last day of the protocol treatment

    From the registration date, the earliest observed event from any of the following events 1. Death from any cause death date 2. The date of the first diagnostic imaging examination that confirmed exacerbation and recurrence.

    Clinical exacerbation diagnosis date if not based on diagnostic imaging 3. If none of the above events are observed, the most recent outpatient consultation date / in hospital

Secondary outcomes

  1. Overall Survival

    Time frame: During the protocol treatment then 18 months from the last day of the protocol treatment

    The period from the registration date to the date of death due to any cause. In the case of survivors, the final surviving confirmation date will be censored.

    In the case of untraceable cases, the last surviving confirmation date before tracking becomes impossible will be censored.

  2. QOL

    Time frame: During the protocol treatment then 18 months

    QOL assessed by FACT-Taxane(Version 4A)

  3. Adverse Event

    Time frame: During the protocol treatment then 18 months

    Adverse Event assessed by CTC(Version 2.0 Japanese version)

Sponsors and collaborators

Lead sponsor

Japanese Gynecologic Oncology Group

Other

Registry information

Official study title

Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense Weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma

Important dates

Study start
2003
Primary completion
2012
Study completion
2012
First posted
Sep 27, 2005
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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